CRED ERP 25

Day 85 • CMS then has until Day 75 to submit their comments on the updated assessment report • If any potential safety patient health exists, the RMS and CMS may have meetings between Day 73 and Day 80 to discussion serious risks • The break-out sessions are intended to create a discussion platform for the RMS, CMS, and if necessary, the applicant • This meeting(s) is to discuss outstanding issues, unresolved comments, and negotiate a consensus between the RMS and CMS • If consensus is reached, then the procedure is closed with market approval

Day 90 -150 •

If consensus is not achieved then CMS must communicate disagreements to the RMS no later than day 90. The RMS should then refer the disagreement (PSRPH) to CMDh levelwithin 7 days after Day 90. • If consensus is reached at CMDh, then the procedure is closed with market approval • If consensus is still not reached, then the process is taken to the CHMP level